O tagata mama'i na maua i le ulcerative colitis (UC) o lo'o ave le mirikizumab, na ausia le maualuga o fuainumera o fa'amagalo falema'i i le 12 vaiaso pe a fa'atusatusa i tagata mama'i o lo'o ave le placebo i le su'esu'ega LUCENT-1 Phase 3 a Eli Lilly ma le Kamupani. O ma'i na fa'aaogaina le mirikizumab na ausia fo'i fa'alelei fa'afuainumera fa'atatau i fa'ai'uga maualuga lona lua e aofia ai fa'ama'i, fa'ailoga, endoscopic ma histologic (tulaga feavea'i o mea'ai) fua, fa'atusatusa i latou o lo'o faia placebo. O fa'ai'uga mai le su'esu'ega fa'aulufale muamua a Lilly o lo'o tu'uina atu toetoe lava i le 17th Congress of the European Crohn's and Colitis Organization (ECCO), lea e faia ia Fep. 16-19, 2022.

"O tagata e maua i le ulcerative colitis o loʻo i ai le mumu o le mucosal i le kolone, lea e mafua ai le tafe toto, malaga soo i le faletaele ma le manaʻoga faanatinati e fai se manava," o le tala lea a Geert D'Haens, MD, Ph.D., tusitala taʻitaʻi ma Polofesa. o Gastroenterology i Amsterdam University Medical Centers. "O Mirikizumab e iai le malosi e faʻaitiitia ai le mumū, fesoasoani i tagata e maua le faʻamagaloga ma faʻaitiitia le manava faanatinati, o se tala fou, faʻamaʻi-centric taunuuga e leʻi suʻesuʻeina muamua i le Vaega 3 faʻataʻitaʻiga mo ulcerative colitis."

O lenei suʻesuʻega faʻavaomalo o 1,162 tagata maʻi na aofia ai maʻi e leʻi faʻataʻitaʻiina se togafitiga faʻaola (biologic-naïve) ma maʻi e sili atu ona faigata ona togafitia oe na ave muamua se bioc na le manuia. O le tasi i le fa o tagata gasegase na togafitia i le mirikizumab (24.2%, n = 210/868) na ausia le tulaga muamua o le faʻamagaloina falemaʻi i 12 vaiaso, faʻatusatusa i le tasi i le fitu i luga ole placebo (13.3%, n = 39/294, p = 0.00006), fa'ailoa mai le fa'aleleia atili o fa'ama'i ma fa'ai'uga po'o latalata fo'i le fofo o le fula. Toeitiiti atoa le lua vaetolu o tagata gasegase o loʻo ave le mirikizumab (63.5%, n = 551/868) na maua le tali faʻafomaʻi, faʻatusatusa i lalo ifo o le afa o tagata gasegase na togafitia i le placebo (42.2%, n = 124/294, p<0.00001). Mo metotia, tagai i le “About the LUCENT-1 Study” vaega i lalo.

Toeitiiti atoa le afa o tagata gasegase o loʻo ave le mirikizumab (45.5%, n = 395/868) na ausia faʻamaʻi faʻamaʻi ile 12 vaiaso, faʻatusatusa i lalo ifo o le tasi vaetolu o tagata gasegase e ave placebo (27.9%, n = 82/294, p<0.001). I le amataga o le fa vaiaso, e sili atu ma le tasi i le lima tagata mamaʻi na ave le mirikizumab (21.8%, n=189/868) na faʻavavevave le faʻaleleia o latou faʻaʻailoga, faʻatusatusa i le tusa ma le tasi i le valu tagata mamaʻi na ave le placebo (12.9%, n=38). /294, p<0.001).

I le amataga o le lua vaiaso ma tumau i le 12 vaiaso, o tagata mamaʻi na togafitia i le mirikizumab sa i ai se faʻaitiitiga faʻafuainumera taua i luga o le 11-point bowel faʻanatinati fua mamafa. I le 12 vaiaso, na maua ai e tagata gasegase se faʻaitiitiga averesi o 2.59 (2.32 i le 2.85) points, faʻatusatusa i le faʻaititia o le 1.63 (1.18 i le 2.09) togi mo tagata mamaʻi ile placebo (p<0.00001). O le 2-vaiaso le fa'anatinati fa'anatinati na mua'i fa'amalamalamaina ae e le'i fa'atonuina fa'atele.

O le aotelega o le talaaga saogalemu e tutusa ma suʻesuʻega muamua o le mirikizumab i le UC ma o loʻo tutusa ma isi faʻamaʻi anti-IL-23p19 i isi vaega togafitiga. O maʻi o loʻo ave le mirikizumab, faʻatusatusa ia i latou i luga o placebo, na lipotia mai le maualalo o taimi o faʻalavelave matuia (mirikizumab: 2.8%, n = 27; placebo: 5.3%, n = 17) ma e le mafai ona faʻagata le suʻesuʻega ona o mea leaga na tutupu ( mirikizumab: 1.6%, n=15; placebo: 7.2%, n=23).

OA MEA E AVEA MAI LENEI TUSI:

In as early as two weeks and sustained through 12 weeks, patients treated with mirikizumab had a statistically significant reduction on an 11-point bowel urgency severity scale.
“Mirikizumab has the potential to significantly reduce inflammation, help people achieve remission and reduce bowel urgency, which is a novel, patient-centric outcome that hasn’t been studied before in a Phase 3 trial for ulcerative colitis.
Patients with moderately-to-severely active ulcerative colitis (UC) who took mirikizumab achieved statistically superior rates of clinical remission at 12 weeks compared to patients taking placebo in Eli Lilly and Company’s pivotal LUCENT-1 Phase 3 study.